Food, drugs, devices › Zimmer Trabecular Metal Technology, Inc.
Device recall: NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Inten
FDA enforcement event 70605 is a device recall by Zimmer Trabecular Metal Technology, Inc. of Parsippany, NJ, initiated 4 Feb 2015 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 16 Jul 2015. Initiation: voluntary: firm initiated. Zimmer Trabecular Metal Technology, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Zimmer Trabecular Metal Technology, Inc., Parsippany, NJ.
Reason for recall
"One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed."
Distribution
"US Distribution in the state of CA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1325-2015 | NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution-Rotating Hinge Knee (RHK)… | 1 unit | Class II | Terminated | 1 Apr 2015 |
Context
Other enforcement events for Zimmer Trabecular Metal Technology, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Feb 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: | Device | Class II | 2 |
| 7 Jul 2016 | The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior col | Device | Class III | 1 |
| 15 Apr 2016 | POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 0058780653 | Device | Class II | 6 |
| 2 Dec 2014 | NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U. | Device | Class II | 1 |
All 5 events for Zimmer Trabecular Metal Technology, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution in the state of CA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Jul 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.